NCT01383018

PROPPER Prospective Registry of Outcomes With Penile Prosthesis

Prospective Registry of Outcomes With Penile Prosthesis for Erectile Restoration (PROPPER)

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 1,457 (actual)
• Sponsor: Boston Scientific Corporation · Industry
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this observational registry is to collect and better understand "real-world" outcomes for men undergoing penile implant surgery to treat erectile dysfunction.

Detailed description

A prospective, multi-center, observational registry to be conducted at multiple sites throughout the United States and Canada, to collect "real-world" penile prosthetic outcomes according to investigators' standard of care. Using questionnaires as well as electronic data collection, investigating physicians will prospectively measure patient responses at regular intervals over a one- to five year period. The physician researchers have identified key metrics for the study including effectiveness, durability, complications, and patient satisfaction; quality of life will also be analyzed, being defined through several validated patient surveys.

Conditions

• Erectile Dysfunction
• Impotence

Interventions

Type	Name	Description
DEVICE	AMS Penile Prosthesis Devices	Non-interventional device registry. Outcomes for patients receiving marketed AMS penile prosthesis devices.

Timeline

• Start date: 2011-06-13
• Primary completion: 2017-11-30
• Completion: 2018-07-25
• First posted: 2011-06-28
• Last updated: 2021-02-12
• Results posted: 2020-02-18

Locations

11 sites across 2 countries: United States, Canada

Regulatory

• FDA-regulated device study